Around 2 000 products are being investigated. Colourbox

Av Anders Göransson den 18 september 2023 10:53

The investigation is conducted by the European Medicines Agency (EMA) and involves a huge number of generics – copies of already authorised medicines. Around 2 000 products in different formulations and doses are being investigated. 

The common denominator is that they have undergone comparative studies at Synapse Labs, a contract research organisation based in Kharadi, India, with the aim of verifying that they are actually equivalent to the original medicine.

During a routine Good Clinical Practice (GCP) inspection of Synapse Lab, the Spanish Medicines Agency found discrepancies so serious that the EMA considers the validity of the study data to be questionable.

Companies that have used the Indian company are now being asked to provide other adequate evidence that their medicines are equivalent to the original medicines. The investigation is conducted by medicines authorities in two EU Member States.

Pending the results, the medicines may continue to be sold in Sweden.

– Yes, that is our decision. We do not believe there is any risk to patients in terms of either efficacy or safety, says Kristina Dunder, the Swedish Medical Products Agency’s representative on the EMA’s Scientific Committee for Human Medicine (CHMP), to Life Science Sweden.

In her opinion, the medicines have already been evaluated based on their quality and the presence of the right components. The uncertainty relates mainly to the actual concentration of the active substances.

“We are now awaiting the investigation. If the companies that market the medicines cannot present data to confirm their similarity to the original, they will have to conduct a new study, and then we may withdraw the medicine pending that study,” says Kristina Dunder.

However, she emphasises that all the products are generics, meaning that other equivalent medicines will be available for patients to use as substitutes.

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